Senior Principal Statistical Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and manage multiple clinical studies, overseeing their statistical and clinical programming deliverables.

• Act as a representative for Statistical Programming in Study Management Team and Clinical Development meetings.

• Evaluate resource requirements and assist with project staffing needs.

• Review documents related to studies, including statistical analysis plans, case report forms, data management plans, database specifications, EDC data structures, and DMC plans.

• Collaborate with Statisticians, Data Managers, Clinical Operations, Medical Monitors, Medical Writing, and other stakeholders.

• Develop, test, and validate SAS programs that generate analysis datasets, tables, listings, graphs, and presentation materials.

• Implement and enhance department-, product-, and study-level macros and utilities.

• Offer technical expertise on intricate programming tasks and compliance with standards.

• Contribute to the development of Statistical Programming policies, standard operating procedures, and controlled documents.

• Liaise with outsourcing partners and vendors.

⛳️ Requirements

• A Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related scientific discipline, or equivalent experience.

• At least 5 years of clinical research and development programming experience utilizing SAS.

• Proficient SAS programming skills capable of handling complex programming tasks and analyses.

• Familiarity with SDTM and ADaM standards.

• Experience in drafting CDISC-standard dataset specifications.

• Experience in generating SDTM and ADaM datasets based on specifications.

• Capability to develop, test, and validate analysis datasets, tables, listings, graphs, macros, utilities, and presentation outputs.

• Expert knowledge and significant hands-on experience with CDISC methodologies.

• Experience leading or collaborating with centralized Statistical Programming teams.

• Background in oncology trials.

• Familiarity with FDA, EMEA, and CFDA clinical trial and regulatory submissions.

• Comprehensive understanding of the drug development process across preclinical, early, late-stage, and/or observational contexts.

• Knowledge of drug development principles and project planning and management.

• Exceptional verbal and written communication skills.

• Ability to work collaboratively in a fast-paced environment.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance coverage.

• Paid Time Off.

• Wellness programs.